Approved consistent with previous terms of clearance: This collection is approved consistent with the agreement that NIH will continue to work with OMB and other interested agencies as they move forward with the rule making process that will eventually define the adverse event reporting framework in response to U.S. Public Law 110-85 (i.e., determining the best method for including in the registry and results databank appropriate results information on serious adverse and frequent adverse events.) These terms of clearance do not preclude the option of NIH using the FDAAA default as a starting point for adverse event reporting. OMB understands that NIH will seek public comments through rulemaking and incorporate prior experience with the optional reporting system to ensure that the default elements are incorporated and displayed in an appropriate and meaningful way
Inventory as of this Action
Requested
Previously Approved
11/30/2018
36 Months From Approved
11/30/2015
224,530
0
168,390
682,535
0
474,873
0
0
0
This information collection request seeks an extension of the existing Paperwork Reduction Act clearance for the collection of clinical trial registration and results information via the ClinicalTrials.gov web site operated by the National Library of Medicine (NLM) under the authority of the Director, National Institutes of Health (NIH). The Office of Management and Budget (OMB) Notice-of-Action authorizing the current 3-year approval of the information collection (OMB No. 0925-0586) was issued August 20, 2012 and is due to expire on August 31, 2015.
The purpose of the clinical trials registry data bank is to enhance patient enrollment and provide a mechanism to track the progress of clinical trials. The information is intended to provide current and reliable information on the broadest possible scale to members of the public, including to physicians and researchers, about the existence, nature, enrollment status, location, eligibility criteria, sponsorship and progress of clinical trials.
This supporting statement includes an adjustment to the burden estimates to reflect recent growth in the number of studies for which registration and results information are submitted on an annual basis to ClinicalTrials.gov. The result is an increased annual burden estimated for registration of 138,000 hours above the previous information collection and an increased estimated annual burden of 74,000 hours for the submission of results information. Much of this increase results from the voluntary use of ClinicalTrials.gov for registration and results submission by those who conduct clinical studies.
$4,826,307
No
No
No
No
No
Uncollected
Mikia Currie 3014350941
No
On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control number;
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
Form 1 PRS Account
Attachment 5 - Privacy Act Review _Clinical Trials gov Extension 2015.doc
Attachment 2 - ClinicalTrials.gov Protocol Data Element Definitions.pdf
NLM Clinical Trials ICR Supporting Statement August 2015 (2).docx
PRS Account